FDA product code IWT: Shield, Gonadal
IWT is the FDA product code for shield, gonadal. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 2 510(k) submissions under IWT, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Shield, Gonadal |
| Device class | Class I |
| Regulation | 21 CFR 892.6500 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IWT clearance
Top IWT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Byers Industries, Inc. | 1 | 1993-05-17 |
| Radiology Design | 1 | 1983-11-21 |
Most recent IWT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930763 | Byers Industries, Inc. | FIGLEAF SHIELD | 1993-05-17 | 94 |
| K833523 | Radiology Design | C.B. RADIOLOGY DESIGN GONADSHIELD | 1983-11-21 | 62 |
Recalls for IWT devices
openFDA lists no recalls for product code IWT.
Frequently asked questions
What is FDA product code IWT?
IWT is the FDA product code for shield, gonadal. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.
What device class is IWT?
Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IWT?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most IWT clearances?
Byers Industries, Inc. (1); Radiology Design (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IWT
- Run a recall and safety report across every IWT manufacturer
- Watch product code IWT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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